BPC March 12 update

Rubius RUBY discontinues phenylketonuria trial - shares fall 39%; Offerings for KTOV and TENX

Price and Volume Movers

Vir Biotechnology, Inc. (Nasdaq: VIR) shares closed up 11% to $37.60 on news it has signed a letter of intent with Biogen Inc. (Nasdaq: BIIB) for the development and clinical manufacturing of human monoclonal antibodies for the potential treatment of COVID-19, the disease caused by the SARS-CoV-2 virus.

Rubius Therapeutics, Inc. (Nasdaq:RUBY) shares closed down 39% following its announcement it has discontinued development of RTX-134 for the treatment of phenylketonuria (PKU). The company noted that data from its Phase 1b trial “were uninterpretable possibly due, in part, to the low dose of cells administered and the sensitivity of the flow cytometry assay used to detect circulating cells.”

Kitov Pharma Ltd. (NASDAQ: KTOV) announced a public offering of 20m units at a price of $0.30 per unit, with each unit consisting of one American Depositary Share (ADS) and one warrant to purchase one ADS, for gross proceeds of $6m. Shares closed down 32% to $0.34.

Tenax Therapeutics, Inc. (Nasdaq: TENX) shares closed down 38% to $0.66 after it announced a registered direct offering of 750,000 shares at a price of $1.1651 per share and pre-funded warrants to purchase up to 1,610,313 shares, for gross proceeds of $2.75m.

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Major price movers (stocks priced > $1.00, volume > 50k):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume:

ADVANCERS:

Tiziana Life Sciences PLC (TLSA): $5.26; +33%.

Mallinckrodt Public Limited Company (MNK): $3.48; +14%.

Seres Therapeutics, Inc. (MCRB): $2.99; +13%.

Vir Biotechnology, Inc. (VIR): $37.60; +11%.

Eloxx Pharmaceuticals, Inc. (ELOX): $3.19; +11%.

DECLINERS:

LogicBio Therapeutics, Inc. (LOGC): $4.22; -40%.

89bio, Inc. (ETNB): $21.05; -37%.

Aquestive Therapeutics, Inc. (AQST): $1.92; -35%.

Selecta Biosciences, Inc. (SELB): $2.08; -33%.

Calithera Biosciences, Inc. (CALA): $3.57; -30%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ALDX – Aldeyra Therapeutics Inc.
Reproxalap (ADX-102)
Sjögren-Larsson Syndrome (SLS)

Phase 3 Development placed on hold - noted March 12, 2020.
$75.3 million

AXSM – Axsome Therapeutics Inc.
AXS-05 STRIDE-1
Treatment resistant depression

Phase 3 Phase 3 data due 1Q 2020.
$2.3 billion

CRBP – Corbus Pharmaceuticals Holdings Inc.
Anabasum (Resunab)
Cystic Fibrosis

Phase 2b Phase 2b data due summer of 2020.
$377 million

CTIC – CTI BioPharma Corp.
Pacritinib - PACIFICA
Myelofibrosis

Phase 3 Phase 3 Spleen Volume Reduction (SVR) data due by the end of 2021.
$69.5 million

FLXN – Flexion Therapeutics Inc.
Zilretta - FX006
Shoulder osteoarthritis (OA) and frozen shoulder

Phase 2 Phase 2 data due 2021.
$316.5 million

ITRM – Iterum Therapeutics plc
Sulopenem
Uncomplicated urinary tract infections (uUTI)

Phase 3 Phase 3 data due 1Q 2020.
$41.5 million

KZR – Kezar Life Sciences Inc.
KZR-616
Dermatomyositis and polymyositis

Phase 2 Phase 2 data due 2H 2021.
$174.8 million

MIRM – Mirum Pharmaceuticals Inc.
Maralixibat - MARCH
Progressive Familial Intrahepatic Cholestasis (PFIC)

Phase 3 Phase 3 data due by the end of 2020.
$345.3 million

NXTC – NextCure Inc.
NC318
Solid tumors

Phase 1/2 Phase 2 initial data due by the end of 2020.
$1 billion

PRVB – Provention Bio Inc.
PRV-031 (teplizumab)
Type 1 diabetes

BLA Filing Rolling BLA filing to commence mid-2020. To be completed 4Q 2020.
$398.4 million

RUBY – Rubius Therapeutics Inc.
RTX-134
Phenylketonuria (PKU)

Phase 1/2 Phase 1b trial to be discontinued - noted March 12, 2020
$344.6 million

SRRK – Scholar Rock Holding Corporation
SRK-015 - TOPAZ
Spinal muscular atrophy (SMA)

Phase 2 Phase 2 interim efficacy data due mid-2020 with top-line data 4Q 2020.
$400 million

SWTX – SpringWorks Therapeutics Inc.
Nirogacestat
Desmoid tumors

Phase 3 Phase 3 update due 2H 2020 with top-line data due 2Q or 3Q 2021.
$1.2 billion

TBIO – Translate Bio Inc.
MRT5005
Cystic fibrosis

Phase 1/2 Phase 1/2 MAD data due initially 3Q 2020. Timeline might be delayed due to COVID-19. Update due at later date.
$648.9 million

TENX – Tenax Therapeutics Inc.
Levosimendan
Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF)

Phase 2 Phase 2 top-line data due 2Q 2020.
$3.9 million